Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1“Erectin Stimulating Gel is nicknamed the INSTANT ERECTION formula.”
Passage 2“Rock Hard Erections.”
Passage 3“Longer-Lasting Erections.”
Passage 4“Zanthoxylum Oil has been used for centuries as an anti-fungal treatment and for its healing properties. It has a numbing effect that makes it perfect for guys who ejaculate too early.”
Passage 5“Peony Extract helps blood circulation and soothes nerves.”
Passage 6No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.128